Phase 2
Completed N=102
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00587431 ↗Enrolled (actual)
102
Serious AEs
43.1%
Results posted
Aug 2014
Primary outcomePrimary: PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy — 9; 14; 13; 12 participants
Summary
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy |
9; 14; 13; 12; 0; 0 | — |
| SECONDARY The Effects of Testosterone Administration on Docetaxel Pharmacokinetics. |
23.9; 23.6 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
- Patient must have a serum testosterone > 180 ng/dl.
- Karnofsky performance status (KPS)>\_70%.
- Patients must have adequate organ function as defined by the following
- laboratory criteria:
- WBC >\_ 3500/mm3
- ANC >\_1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin >8.0g/dL
- Creatinine \_ grade 3.
- Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
- Prior chemotherapy
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
Data sourced from ClinicalTrials.gov (NCT00587431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.